Pilot Human Study Using Transnasal Cooling on Cardiac Arrest Subjects

Period of Performance: 04/01/2016 - 03/31/2017

$937K

Phase 2 SBIR

Recipient Firm

KEY Technologies, Inc.
Baltimore, MD 21230
Principal Investigator
Principal Investigator

Abstract

? DESCRIPTION (provided by applicant): This project will result in the creation of a clinical-grade product called the CoolStat that will be able to quickly and safely cool the brain and body after cardiac arrest. The CoolStat is designed to be initiated by EMS personnel to start early cooling post arrest, which has been shown to improve survival rates and neurological outcomes. As part of this overall project, we will (1) create the clinical-grade CoolStat product for use in human trial; (2) obtain FDA approval to use the product in a pilot cardiac arrest study (via an IDE); and (3) complete the pilot study in cardiac arrest victims to measure safety and cooling efficacy. Current techniques to provide early cooling to patients are not effective, relying on some form of active cooling, whether by ice packs, cold saline or evaporative fluids. Our approach is novel in that we are harnessing a physiologic process that triggers the body to cool itself. There are no active cooling systems or evaporative chemicals. Our cooling method uses only dry, ambient air that we blow into the nasal track and then extract the moisturized air from the mouth. This sets up an evaporating cooling heat exchange, which effectively pulls energy and heat out of the body, cooling the brain at a rate of about 1 C in 10 minutes. This project will be an extension of previous grant work we have completed, including pre-clinical and feasibility testing in humans. We will complete this proposed project in three sequential stages. In Year 1, we will transition from a bench-top prototype of the product to making about 50 clinical-grade devices. We will also obtain an IDE from the FDA to run the human study. In Year 2, we will implement the human study by working with our strategic partner, Zoll Medical, a leading commercial company in the field of patient temperature management. Zoll has agreed to partner with us to allow them to better assess the benefit of our cooling technology. Tentatively, the human study will be conducted at 5 sites that have been pre-approved by Zoll. In Year 3, we will finish the human study, analyze and publish the results, and hopefully transition into a pivotal study with Zoll. This work will validate a new method for inducing hypothermia that can be easily deployed during treatment of out-of-hospital cardiac arrest, as well as other ischemic injuries to the brain and the heart. It will prove the clinical value of early cooling and hopefully become a standard of care. Ultimately, we plan to leverage this grant program into the creation of a family of cooling products that can be used for cardiac arrest, ST elevated myocardial infarction, stroke and other potential indications.